Core Insights - Insight Molecular Diagnostics Inc. (iMDx) has appointed Steven Tahmooressi as Vice President of Marketing to lead the marketing efforts for its upcoming clinical kitted assay, GraftAssureDx, set to launch in 2026 [2][5][6] - The company aims to democratize access to molecular diagnostic testing, focusing initially on transplant rejection testing through its GraftAssure family of assays, which includes GraftAssureCore and GraftAssureIQ [5][11][14] - The addressable market for kitted transplant rejection testing is estimated at $1 billion, with GraftAssure tests measuring donor-derived cell-free DNA (dd-cfDNA), a key biomarker for transplant rejection [8][10] Company Overview - iMDx, formerly known as Oncocyte Corp., is a precision diagnostics technology company headquartered in Nashville, Tennessee, since June 2025 [12] - The company specializes in quantifying dd-cfDNA, which is widely recognized as a biomarker for transplant rejection [11][12] - GraftAssureCore is currently reimbursed by Medicare and performed at iMDx's CLIA-certified laboratory in Nashville, while GraftAssureIQ is available for research use only [7][14] Leadership and Experience - Steven Tahmooressi brings over 25 years of healthcare industry experience, having previously held significant roles at Astellas Pharma, Abbott Laboratories, and Bristol-Myers Squibb [3][4][6] - His expertise includes leading successful product launches in transplantation, oncology, and immunology across various global markets [5][6][9] Product Development and Market Strategy - iMDx is preparing for FDA authorization of GraftAssureDx in 2025, which will be a clinical molecular diagnostic test kit aimed at improving testing access for kidney transplant patients [5][7][14] - The company has invested three years in developing its kitted product for transplant rejection testing, indicating a strong commitment to this market segment [5][8]

Core Insights - Insight Molecular Diagnostics Inc. (iMDx) is actively participating in two significant industry conferences to showcase its GraftAssure™ technology and its clinical kitted test under development [1][4] - The company aims to highlight the clinical applications of transplant rejection testing, particularly in longitudinal surveillance and therapeutic response monitoring [2][3] Conference Participation - iMDx is hosting a symposium at the IATDMCT annual meeting in Singapore from September 21 to 24, 2025, focusing on the benefits of in-house testing for transplant rejection [2][6] - The company will also present at the ASHI annual meeting in Orlando, Florida, from October 6 to 10, 2025, discussing GraftAssureIQ, a research-use-only test kit [4][8] Technology and Product Development - GraftAssure technology is designed to detect transplant rejection and monitor treatment response, significantly reducing time-to-rejection diagnosis in high-risk kidney transplant patients [3][5] - The GraftAssureDx, currently in development, is expected to be submitted for FDA review by the end of 2025, targeting an estimated $1 billion addressable market for kitted transplant rejection testing [5][15] Strategic Partnerships - iMDx is collaborating with Bio-Rad Laboratories to present on GraftAssureIQ, emphasizing the potential of in-house testing for convenience and efficiency in transplant care [4][5] Market Position - The company is focused on democratizing access to molecular diagnostic testing, particularly for kidney transplant patients, utilizing donor-derived cell-free DNA (dd-cfDNA) as a biomarker for transplant rejection [16][13]

Core Insights - Oncocyte Corp. has announced a positive update regarding the pricing of its next-generation lab-developed test (LDT), GraftAssureCore, which enhances its position in the transplant rejection testing market and indicates potential growth in its estimated $1 billion total addressable market [1][6] Pricing and Reimbursement - The Centers for Medicare & Medicaid Services (CMS) has increased the reimbursement rate for GraftAssureCore to $2,753 per result, up from $2,222 for first-time testing and $1,029 for subsequent tests [2] - This new pricing aligns with existing competitive technologies and expands market appeal for future FDA-cleared kitted products at transplant centers [6] Company Strategy and Future Prospects - Oncocyte has invested significantly in improving the scalability and manufacturability of its workflow, which supports its kitted test program [3] - The new reimbursement rate establishes a benchmark for future kitted tests, such as GraftAssureDx, which is expected to be submitted for FDA review by the end of the year [3] - The company anticipates that receiving FDA authorization will enable broader adoption of its technology, allowing transplant centers to access high-quality, FDA-cleared kits with established reimbursement [4] Clinical Trials and Market Engagement - Oncocyte has received approval from a Central Institutional Review Board for its clinical trial, with final preparations underway at participating transplant centers [4] - The company expects participation from three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume [4] Technology and Market Position - Oncocyte's technology quantifies donor-derived cell-free DNA (dd-cfDNA), which has been established as a trusted biomarker for transplant rejection [5] - The company is rebranding its test portfolio under the GraftAssure brand, with GraftAssureCore being the new name for its previously marketed VitaGraft assay [5]

Core Viewpoint - Oncocyte Corp. is making significant progress towards initiating a clinical trial for an organ transplant rejection monitoring test kit, which is essential for obtaining regulatory authorization to market the product [1][6]. Company Progress - Oncocyte has completed the clinical trial design and received approval from a central institutional review board (IRB) [2]. - The company expects to include three of the top 10 transplant centers in the U.S. as participants in the clinical trial, representing nearly 10% of the U.S. transplanted organ volume [3]. - Oncocyte estimates that transplant rejection testing generates approximately $500 million in annual revenue in the U.S., with a global addressable market exceeding $1 billion [4]. Market Engagement - The transplant community is enthusiastic about the opportunity to conduct testing in-house, with major transplant centers supporting Oncocyte's efforts [5]. - Oncocyte plans to announce its National Principal Investigator (NPI) soon and will host a conference call to introduce this key opinion leader [5]. Regulatory Pathway - The upcoming clinical trial is the only requirement for FDA authorization of Oncocyte's test kit, which is being pursued through a Class II de novo pathway [6]. - Oncocyte is preparing for its second and final Q-Submission (Q-Sub) meeting with the FDA, following productive discussions in previous meetings [7][8].